Data / Medical devices / United States / Medicomp, Inc.
Medicomp, Inc.: FDA-registered device maker in Melbourne, FL, United States, 3 510(k) clearances
Medicomp, Inc. is registered with the FDA (registration 1033601) in Melbourne, FL, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated January 10, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1033601
- Address
- 600 Atlantis Rd --, Melbourne, FL, United States, 32904
- Owner or operator
- Medicomp, Inc. (1033601)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 17, 2009
- Registered through
- 2026
- Brand names listed
- Epicardia 5000, Epicardia Anywhere, TelePatch Cardiac Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Electrocardiograph, Ambulatory, With Analysis Algorithm | MLO | 2 | Specification developer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 10, 2018 | K173170 | Epicardia Anywhere | DSI | Substantially Equivalent | Medicomp, Inc. | accessdata.fda.gov |
| December 21, 2016 | K161916 | TelePatch Cardiac Monitor | DRG | Substantially Equivalent | Medicomp, Inc. | accessdata.fda.gov |
| May 15, 2009 | K090834 | EPICARDIA 5000 | DSI | Substantially Equivalent | Medicomp, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Detector And Alarm, Arrhythmia
- All makers of Transmitters And Receivers, Physiological Signal, Radiofrequency
- All makers of Electrocardiograph, Ambulatory, With Analysis Algorithm
Updated January 10, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.